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Status unknownNCT03443037Updated Sep 6, 2018

Benefits of Amantadine in Patients With Coma State

An observational study in Coma; Prolonged and Amantadine, sponsored by Dokuz Eylul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Dokuz Eylul University · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 65 Years
Sex
All
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Study summary

The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.

02

Conditions studied

  • Coma; Prolonged
  • Amantadine

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Keywords

  • Coma
  • Disability
  • amantadine
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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.

Inclusion criteria

  • ≥18 years, ≤ 65 years
  • GCS score ≤ 8
  • Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

Exclusion criteria

Exclusion Criteria:

  • \<18 years, > 65 years
  • Patients admitted to the critical care without diagnosis of coma state
  • Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
  • Metastatic malignant neoplazm
  • Congenital or acquired brain function problem (cerebral palsy, autism etc)
  • Patients with amantadine allergy
  • Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • Amantadine group

    Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician

    Drug: amantadine sulphate

  • Control group

    Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin

Interventions

  • Drugamantadine sulphate
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What researchers measure

Primary outcomes

  1. Change in Glascow Coma Score

    Glascow Coma Score

    Time frame: 1. At the time of enrollment 2. 12 weeks after the enrollment

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03443037
Lead sponsor
Dokuz Eylul University
Responsible party
Begum Ergan (Staff in the department of pulmonary and critical care medicine, Dokuz Eylul University) — Principal investigator
First posted
Feb 22, 2018
Start date
Mar 1, 2016
Primary completion
Jul 1, 2019 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Sep 6, 2018

Study contacts

Kutlay Aydin, MD
Contact
kutlayaydin@hotmail.com
+905322649294
Necati Gokmen, MD
study chair · Dokuz Eylul University
Kutlay Aydin
principal investigator · Dokuz Eylul University
Kutlay Aydin
study director · Dokuz Eylul University
Begum Ergan
principal investigator · Dokuz Eylul University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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